Jobs · Analyst · Maryland

Human Subjects Protection Scientist

Alaka`ina Foundation Family of Companies · Silver Spring, MD · 2 mo ago
AnalystFull-time

Description of Responsibilities

  • Provide human subjects protection regulatory and scientific support services via the review of research protocols submitted to the WRAIR, HSPB to include participating in project/protocol development/modification.
  • Evaluate research protocols and protocol lifecycle actions (e.g., amendments, continuing reviews, safety reports, deviations, etc.) for compliance with relevant regulatory requirements and draft a Protocol Evaluation Form (PEF)/pre-review for each action received.
  • Reviews and writes a variety of scientifically technical documents for the purposes of evaluating against applicable regulations, policies and procedures.
  • Provides human subjects protection regulatory and scientific support services via the review of research protocols submitted to an Army command and its detachments.
  • Evaluating research protocols and protocol lifecycle actions for compliance with relevant regulatory requirements and drafting a protocol evaluation form (PEF)/pre-review for each review conducted.
  • Managing the approval process for these actions by drafting/triaging review/approval memoranda on behalf of the army command and its detachments.
  • Developing new policies/procedures, as well as recommend revisions to existing policies and procedures, at the request of the TOCOR or HSPB Director.
  • Representing HSPB at meetings pertaining to human subject protection issues, as needed.
  • Participating in site assistance visits to OCONUS laboratories, as needed, and draft site assistance visit (SAV) reports following visits to OCONUS laboratories.
  • Reviewing and documenting investigator’s credentials. The PEF/pre-review will include review and documentation of investigator credentials.
  • Writing protocol minutes and provision of meeting minutes’ excerpts.
  • Providing training in human subjects’ protection and quality of records to investigators and other staff, as needed.
  • Updating the HSPB protocol database/electronic records management system in a timely manner.
  • Assisting in providing support in preparation for IRB meetings, to include preparing/participating in pre-meetings, as well as, setting up/clearing up the room for the day of the meeting.
  • Other duties as assigned by Supervisor.

Required Degree/Education/Certification

  • Master of Science (MS) in allied sciences with two (2) years IRB regulatory experience;
  • or Bachelor’s degree in allied sciences with five (5) years IRB regulatory experience.

Required Skills and Experience

  • Ability to serve as the subject matter expert in required areas of expertise and provide industry best practice solutions to extremely complex problems being addressed.
  • Have the ability to analyze extremely complex problems and recommend, monitor and execute best practice solutions to executive level management.
  • Good written and oral communication skills, along with the ability to work well in teams.

Desired Skills and Experience

  • Previous DoD regulatory experience.

Citizenship and Clearance

  • Must be a U.S. Citizen
  • Must be able to pass and maintain an IT III background check

Benefits

  • Competitive salaries
  • Eligible employees enjoy a 401K plan with company match
  • Medical, dental, disability, and life insurance coverage
  • Tuition reimbursement
  • Paid time off
  • 11 paid holidays
  • Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • Bering-Alaka`ina Holdings (BAH) is a fast-growing government service provider
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
  • We are an Equal Opportunity/A

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